A Multi-Centered, Two-Arm, Randomized Study Comparing the Effects of AAT-023 (Zuragen) Solution, and Heparin on the Incidence of Catheter Related Blood Stream Infections in Tunneled Chronic Central Venous Catheters for Dialysis
NCT ID: NCT00628680
Last Updated: 2008-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
415 participants
INTERVENTIONAL
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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AAT-023 (Zuragen Arm)
Active experimental consisting of AAT-023 (Zuragen)solution
AAT-023 solution (Zuragen)
Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks
Heparin
5000 units diluted with normal saline to the exact catheter lumen volume
Heparin
Hepaarin 5000 units diluted with normal saline to the exact catheter lumen volume.
Interventions
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AAT-023 solution (Zuragen)
Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks
Heparin
Hepaarin 5000 units diluted with normal saline to the exact catheter lumen volume.
Eligibility Criteria
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Inclusion Criteria
2. CVCD with average dialysis flow rate over 300 mL/min for three most recent visits.
3. Expectation by Investigator that CVCD may be needed for up to 26 weeks.
4. Dialysis catheter is of three types a) single body with single entry and exit, b) single body with split ends, c) twin catheter with one catheter for removal of blood and another for return.
5. Kt/V \>1.1 or equivalent URR
6. Negative serum pregnancy unless surgically sterile or post menopausal for \>1yr.
7. Negative blood culture result from pre-enrollment blood sample draw.
8. Ability of patient to sign and understand the informed consent.
9. Most recent lab results don't indicate hypocalcemia (\<7mg/dL) or thrombocytopenia (\<20,000)
10. Avg. systolic blood pressure \>90 mmHg as measured during the most recent three dialysis treatments.
11. Lack of signs of current blood stream infection at the beginning of the prior three dialysis treatments.
Exclusion Criteria
2. Active bleeding from any site or a documented positive stool hemocult test within 28 days of enrollment in study.
3. Bloodstream infection,exit site infection or any infection requiring antibiotic use within 14 days of enrollment for any antibiotic listed in section 4.2.3 or within 30 days of enrollment for Vancomycin or any other antibiotic not listed in section 4.2.3 of the protocol
4. Inability to comply with the conditions of, or complete the protocol in the opinion of the Investigator.
5. Pregnant or breast feeding.
6. Documented allergy to sodium citrate, methylene blue, methyl/paraben and/or propyl paraben.
7. Documented chronic intrinsic coagulopathy evidenced by persistently and significantly elevated Prothrombin (INR\>3), Partial Thromboplastin Time (PTT\>60 seconds), or thrombocytopenia (platlet count \<20,000/mm).
8. Malignancy requiring chemotherapy or radiation treatment within 180 days of enrollment.
9. Documented requirement for \>5,000 units of Heparin per catheter lumen to maintain catheter patency (with decrease in blood flow demonstrated at 5,000 units per lumen Heparin catheter lock) with current catheter.
10. Contraindications to citrate or taking drugs that may interact with citrate.
11. Documented history of glucose-6-phosphate dehydrogenase deficiency (G6PD or Drug-induced methemoglobinemia).
12. Participation in another research study.
13. Co-morbidities, such as HIV, active hepatitis or recent transplants, that in the opinion of the Investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results and would make the subject inappropriate for entry into this study.
14. Unknown priming volume of catheter lumens.
15. Redness of over 1 cm diameter or pus around the catheter exit site.
18 Years
ALL
No
Sponsors
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Ash Access Technology
INDUSTRY
Responsible Party
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Ash Access Technology
Locations
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Western New England Renal & Transplant Associatea
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hypertension & Renal Research Group
Buffalo, New York, United States
Bayview Nephrology, Inc.
Erie, Pennsylvania, United States
Kidney Associates, PLLC
Houston, Texas, United States
Southwest Houston Research, LTD
Houston, Texas, United States
Fox Valley Nephrology Associates
Appelton, Wisconsin, United States
Bakersfield Dialysis Center
Bakersfield, California, United States
Renal Medical Associates
Lynwood, California, United States
Nephrology & Hypertension Associates, PC
Middlebury, Connecticut, United States
Brandon nephrology
Brandon, Florida, United States
Gulf Breeze Dialysis Center
Dunedin, Florida, United States
Bayonet Point Hudson Kidney Center
Hudson, Florida, United States
Outcomes Research International, Inc.
Hudson, Florida, United States
Bay Breeze Dialysis
Largo, Florida, United States
New Port Richey Kidney Center
New Port Richey, Florida, United States
Discovery Medical Research Group
Ocala, Florida, United States
Nephrology consultants
Orlando, Florida, United States
Hernando Kidney Center
Spring Hill, Florida, United States
Nephrology Associates, P.C.
Augusta, Georgia, United States
MId Atlantic Nephrology Associates, PA
Baltimore, Maryland, United States
Caritas St. Elizabeth Center
Boston, Massachusetts, United States
Countries
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References
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Maki DG, Ash SR, Winger RK, Lavin P; AZEPTIC Trial Investigators. A novel antimicrobial and antithrombotic lock solution for hemodialysis catheters: a multi-center, controlled, randomized trial. Crit Care Med. 2011 Apr;39(4):613-20. doi: 10.1097/CCM.0b013e318206b5a2.
Other Identifiers
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AATML2003-A
Identifier Type: -
Identifier Source: org_study_id
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